BC Biomedical DA-2003 User Manual

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User Manual

DA-2003

Defibrillator Analyzer

CONTENTS

I. MANUAL REVISION RECORD.................................. 2

II. INTRODUCTION ........................................................ 3

2.1 Features

2.2 General Information

III. SPECIFICATIONS ...................................................... 4

IV. INSTALLATION.......................................................... 7

4.1 Receipt, Inspection and Return

4.2 Setup

4.3 Power

4.4 Internal Paddles

4.5 Special Contacts

V. OPERATING............................................................... 9

5.1 Control Switches and Connections

5.2 Menu and Function Keys

5.3 Menu and Messages

5.4 Test Result Printouts

VI. TESTING ...................................................................13

6.1 Introduction

6.2 Test Preparation

6.3 Energy Test

6.4 Cardioversion Test

6.5 Maximum Energy Charging Time Test

VII. WARRANTY ............................................................17

VIII. TECHNICAL SUPPORT ............................................17

I. MANUAL REVISION RECORD

This record page is for recording revisions to your DA-2003 User Manual that have been published by BC Biomedical or its authorized representatives. We recommend that only the management or facility representative authorized to process changes and revisions to publications:

• Make the pen changes or insert the revised pages;

• Ensure that obsolete pages are withdrawn and either disposed of immediately, or marked as

superseded and placed in a superseded document file, and;

• Enter the information below reflecting that the revisions have been entered.

Rev No Date Entered Reason Signature of Person Entering Change

0 - Initial Release

1 11/12/04 Part Number Changes KLB

BC Biomedical DA-2003 User Manual 11/04

II. INTRODUCTION

2.1 Features

The DA-2003 Defibrillator Analyzer is a precision instrument for testing defibrillators, and is designed to be used by trained service technicians. It measures the energy output, and ensures that the defibrillator complies with specified requirements. DA-2003 has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the DA-2003 contact plates. Thus, the defibrillator is connected through the load resistance. When the defibrillator is discharged, DA-2003 calculates and displays the energy delivered.

2.2 General Information

Temperature Requirements +15°C to +35°C when operating

0°C to +50°C in storage Display Type LCD graphic display Alphanumeric format 6 lines, 40 characters

Data Input/ Output (2)

Power

Mechanical Specifications

Housing High impact plastic case Height 9.8 cm 3.9 in. Width 24.8 cm 9.8 in. Depth 28.0 cm 11.0 in. Weight 1.85 kg (with battery) 4.1 lbs.

Printer Port

Standard Accessories

110 V or 220 V AC Adapter (P/N BC20-00429) Internal paddle-contact adapter (P/N BC20-00430) Snap-to-banana adapters (10 pk) (P/N BC20-17024) DA-2003 User Manual Protective Cover (P/N BC20-00427)

Additional Accessories Defib. paddle adapter (specify defibrillator type) Soft Carrying Case (P/N BC20-30108)

Storage

Store in the carrying case in dry surroundings within the temperature range specified, without battery. There are no other storage requirements.

Parallel printer port (1); Bi-directional RS -232C (1) for Computer control

2 x 9 volt alkaline Battery Duracell



MN1604 (or equivalent) for 20 -25 operational hours, or 240 VAC (Battery Eliminator), 115 VAC for US.

Centronics Interface

Periodic Inspection

The unit should be calibrated every 12 months.

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III. SPECIFICATIONS

1. Energy Output Measurement

High Range

Voltage <5000 volts Maximum current 120 amperes Maximum energy 1000 Joules Accuracy

Trigger level 100 volts Playback amplitude 1 mV/1000 V Lead I Test pulse 100 + 4 Joules

Low Range

Voltage <1000 volts Maximum current 24 amperes Maximum energy 50 Joules Accuracy

Trigger level 20 volts Playback amplitude 1 mV/200 V Lead I Test pulse Approx. 4 Joules Load Resistance Display Resolution 0.1 Joules Measurement Time Window Abs. Max. Peak Voltage 6000 volts Pulse Width 100 ms

Cardioversion

Oscilloscope Output

High measure range 1000:1 amplitude-attenuated Low measure range 200:1 amplitude-attenuated

Waveform Storage And Playback

Discharge can be viewed via ECG outputs and paddles. Output: 200:1 Time Base expansion.

Sync Time Measurements

Timing window Starts - 40 ms at each R-wave peak. Test waveforms All waveform simulations available. Delay time accuracy

Charge Time Measurement From 0.1 seconds to 99.9 seconds.

± 2 % of reading for >100 Joules ± 2 Joule of reading for <100 Joules

± 2% of reading for >20 Joules ± 2 Joule of reading for <20 Joules

50 ohms ± 1%, non-inductive (<1 µH)

100 ms

Measured time delay ± 2 ms

± 1 ms

2. ECG Wave

ECG General

Lead configuration 12-lead simulation. RL, RA, LA, LL, V1-6

Output impedance Limb leads 1000 ohms to RL

V Leads 1000 ohms to RL

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All other signals are in relative proportion to Lead amplitude as follows: The amplitudes are shown for a Lead I amplitude by 1 mV: Lead I 1.0 mV (LA - RA) Lead II 1.5 mV (LL - RA) Lead III 0.5 mV (LL - LA) V Lead 1.5 mV (V - 1/3 (LL+LA+RA))

High Level Output (ECG Jack) 1/4" standard phone-jack with an amplitude of 1V/mV of low level Lead II signal

Defibrillator Contact Plates Same amplitude as Lead I low level ECG. 1 mV between contact surfaces.

Playback 200 to 1 time-base expansion of defibrillator pulse by playback to ECG Leads

Manual ECG Performance Test DC Pulse 4 seconds 1.0 mV Square wave 2 Hz 1.0 mV p-p biphasic Triangular wave 2 Hz 1.0 mV Sine 0.1, 0.2, 0.5, 10, 40, 50, 60, and 100 Hz Amplitude 0.5, 1.0, 1.5, 2.0 mV (Lead II) Accuracy

ECG Performance Test Gain/Damping 2 Hz square wave Frequency Response Low Frequency 4 second DC pulse Band Pass 10 Hz sine Monitor -3dB point: 40 Hz sine Power Line Notch Filter Linearity 2 Hz triangle wave

Normal Sinus Rates 30, 60, 80, 120, 180, 240 and 300 BPM. Accuracy Amplitudes 0.5, 1.0, 1.5 and 2.0 mV (Lead II) Accuracy

Automatic ECG Rate Test

Arrhythmia Selections

vfib Ventricular Fibrillation afib Atrial Fibrillation blk II Second degree A-V block RBBB Right Bundle Branch Block PAC Premature Atrial Contraction PVC_E Early PVC

± 5 % (Lead II 1.0 mV)

50 Hz sine

± 1% of selection

± 5 % (Lead II 1.0 mV)

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PVC_STD PVC PVCRonT R on T PVC mfPVC Multifocal PVC bigeminy Bigeminy run5PVC Bigeminy Run of 5 PVCs vtach Ventricular Tachycardia

Shock Advisory Test Algorithms ASYS Asystole SVTa_90 Supraventricular Tachycardia PVT_140 PVT_ 160 MVT_140 MVT_160 CVF Course Ventricular Fibrillation FVF Fine Ventricular Fibrillation

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IV. INSTALLATION

4.1 Receipt, Inspection and Return

1. Inspect the outer box for damage.

2. Carefully unpack all items from the box and check to see that you have the following items:

• DA-2003 Defibrillator Analyzer

• 110 V or 220 V AC Adapter

• Internal paddle-contact adapter

• Ground contact adapter

• 10 pack, Snap-to-banana adapter

• DA-2003 User Manual

3. If you note physical damage, or if the unit fails to function according to specification, inform the supplier immediately. When BC Biomedical or the company’s representative, is informed, measures will be taken to either repair the unit or dispatch a replacement. The customer will not have to wait for a claim to be investigated by the supplier. The customer should place a new purchase order to ensure delivery.

4. When returning an instrument to BC Biomedical, or the company representative, fill out the address label, describe what is wrong with the instrument, and provide the model and serial numbers. If possible, use the original packaging material for return shipping. Otherwise, repack the unit using:

• A reinforced cardboard box, strong enough to carry the weight of the unit.

• At least 5 cm of shock-absorbing material around the unit.

• Nonabrasive dust-free material for the other parts.

Repack the unit in a manner to ensure that it cannot shift in the box during shipment.

BC Biomedical’s product warranty is on page 26 of this manual. The warranty does not cover freight charges. C.O.D. will not be accepted without authorization from BC Biomedical or its representative.

4.2 Set-up

1. Equipment connection is as shown in the typical setup below. For direct communication to printer attach the printer cable to the 25-pin outlet port on the DA-2003.

BC Biomedical DA-2003 User Manual 11/04

4.3 Power

1. Main On/Off Switch. DA-2003 should remain off for at least 5 seconds before switching on again, in order to allow the test circuits to discharge fully.

2. Low Battery Power. If battery power falls below 6.9 volts (± 0.3 volts), the display will show 'Change battery, and reset system'. This means that the battery should either be replaced or the instrument should be connected to a battery eliminator. The main switch has to be switched off and then on again in order to use the instrument.

Do not use mercury, air or

NOTE

carbon-zinc batteries.

3. Changing Batteries. Open the compartments in the base of the instrument, replace the old batteries with new ones, and close the compartment covers. Use 9-volt alkaline batteries (Duracell



MN1604 or similar).

4. Battery Eliminator. BC Biomedical’s AC Adapter plug-in power supply

Remove the batteries and

NOTE

disconnect the AC Adapter if you do not intend to use the DA-2003 for an extended period of time.

transformer allows you to use the DA-2003 anywhere a standard electrical outlet is available. To attach the AC Adapter insert the adapter’s small connector into the micro jack labeled “Batt. Elim. 9V DC” on the right rear of the unit. Plug the large connector into the nearest standard electrical outlet.

4.4 Internal Paddles

To be able to test defibrillators with internal paddles, an internal paddle adapter has to be used. These contacts have a banana plug that is attached to the standard paddle contact, and which is protected by a plastic insulation washer.

4.5 Special Contacts

Certain defibrillators (automatic models and those with pacer options) have special contacts that are fastened to the electrodes attached to the patient. BC Biomedical has special adapters to suit the majority of these defibrillators. These are available as accessories. They are more or less the same as the internal pad adapter except that they have a special adapter on the top, which matches the contact on the defibrillator. Defibrillator paddle adapter (specify defibrillator type)

BC Biomedical DA-2003 User Manual 11/04

5.1 Control Switches and Connections

Front Panel

V. OPERATING

DA-2003

1. Power Switch

2. Range Switch

3. LCD Display

4. Function Keys

5. Contact Surfaces

6. Low Level ECG Connectors

Turns the power on and off.

Switches between Low and High ranges of defibrillator energy.

Shows messages, test results and function menus.

Fl - F5 are used to select the functions shown on the bottom line of the LCD display, i.e., for selecting the function that is directly above the key.

The defibrillator’s paddles are placed on these so that the discharged energy passes through the instrument in defib. mode and that the pacer signal passes through the instrument with a fixed 50 ohm load in the PACE mode.

10 color-coded 4 mm safety terminals with

snap-to-banana adapters.

BC Biomedical DA-2003 User Manual 11/04

Rear Panel

7. High Level ECG Jack

1/4” standard phone-jack for amplitude of 1 V/mV of low level Lead 1 signal.

8. Oscilloscope Output

9. RS-232 Serial Port

10. Printer Outlet Port

11. Location of Batteries

BNC-contact for attenuated signal in real time.

9-pin D-sub

14-25 pin D-sub

2 compartments in the base of the instrument can be opened to replace the batteries.

12. Battery Eliminator Socket

5.2 Menu and Function Keys

Battery contact for connecting 9V 30 mA battery eliminator.

The DA-2003 uses display and programmable function keys to provide flexibility and control over the operations. The upper part of the screen displays messages, status and results. The menu bar is at the bottom of the display. The function keys are numbered from Fl to F5.

A function is selected by pressing the key located directly under the Menu Item displayed in the menu bar. A menu unit is written in capital letters. The menu has two pages. The next pages of the menu are selected by pressing more-2, or more-1.

5.3 Menu and Messages

1. Startup Screen. The following screen will be displayed for 2 seconds after the DA-2003 has been switched on.

DA-2003

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2. Main Menu

a. Main Menu Bar (Page 1) - Mode switch in Low or High position.

b. Second Menu Bar (Page 2)

3. ECG WAVES (F1).

Choose desired wave by pressing UP (F2) or DOWN (F3). Save this under ‘Wave” in the

STATUS field by pressing SELECT (F4). Press CANCEL (F5) to cancel selection.

4. PERF. WAVE (Performance ECG) (F2).

Choose desired selection by pressing UP (F2) or DOWN (F3). Save this under ‘Wave” in the

STATUS field by pressing SELECT (F-4). Press CANCEL (F5) to cancel selection.

5. CHARGE TIME (F3). Used to test the battery and charging capacitor in the defibrillator. It changes the text ‘Delay’ to ‘Chrg T : xx.x S’ in the RESULT field in the main menu.

6. PRINT HEADER (F4). Automatically writes a heading for the new test protocol.

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7. WAVE AMPL. (Wave Amplitude) (F1).

Choose desired amplitude by pressing UP (F2) or DOWN (F3). Save this under ‘Ampl” in the

STATUS field by pressing SELECT (F-4). Press CANCEL (F5) to cancel selection.

8. PLAY PULSE (F2) enables playback of the last discharge. See the discussion on playback of energy wave on page 4-3.

9. SYSTEM TEST (F1)

Choose a test variant by pressing UP (F2) or DOWN (F3) or TEST PULSE (F1). Press

CANCEL (F5) to cancel selection. Also, Chapter 5, Control and Calibration, for additional information on ‘ECG0’, ‘ECG+’ and ‘ECG-’ (paragraphs 5.4.10-12) and ‘A/D-read’ (paragraph

5.4.20). ‘Memory’ is for factory testing.

10. REMOTE CONTR. (Remote Control) (F4) enables communication with a PC with test automation software.

Note

DA-2003 has an internally generated test pulse. The control pulse is set at 1.2 Joules in the Low range and

28.5 Joules in the High range. The test pulse is not a calibration pulse, and should not be used as an indication of the general accuracy of the instrument. The

ulse is a good control for testing functions.

test

5.4 Test Result Printouts

DA-2003 automatically prints out the test results, via the printer output, after each discharge generated. Select PRINT HEADER (F4) if you want to print out a page with a new header.

BC Biomedical DA-2003 User Manual 11/04

VI. TESTING

6.1 Introduction

DA-2003 measures the energy output, and ensures that the defibrillator complies with specified requirements. It has a built-in load resistance of 50 ohms, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the DA-2003 contact plates. Thus, the defibrillator is connected through the load resistance. When the defibrillator is discharged, DA-2003 will calculate and display the energy delivered.

Defibrillator energy is defined as an integral of the moment of the discharged energy from the defibrillator. The energy is equal to the square of the voltage, divided by the load resistance.

E = Ø p dt = Ø V2 / R dt = Ø V2 dt / R

DA-2003 measures and records the voltage pulse every 100 µs, 1000 times, for a total time of 100 ms. The squares of the voltages are then summed, multiplied by 100 µs, and divided by the load resistance, 50 ohms.

1000 1000

E = Ø (V2) • dt / R = Ø (V2) • 100 µs / 50 ohms

0 0

The unit for energy is 'joule', which is equal to Ws (Watt second).

6.2 Test Preparation

1. If checking ECG monitoring, prompting, or triggering from the ECG, connect the low level or high level ECG connectors to the ten 4 mm AHA color-coded safety terminals or standard phone jack, as appropriate.

2. Switch the DA-2003 on. The following will be displayed in the LCD display for about two seconds:

DA-2003

3. The following main menu will then appear. It will show LOCAL.

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6.3 Energy Test

1. Select a suitable energy range using the mode switch.

• Use the HIGH range for normal adult testing.

• Use the LOW range for low energy testing, where the energy does not exceed 50 Joule

and the peak voltage does not exceed 1200 volts.

2. Securely place the defibrillator paddles on the DA-2003 contact plates, and discharge the

defibrillator. The APEX (+) pad should be connected to the right-hand plate, and the STERNUM pad to the left plate. This ensures correct signal polarity for the oscilloscope output. A reversal of this configuration will not damage the DA-2003, nor will it give incorrect energy readings. However, the polarity of the oscilloscope output will simply be reversed. The discharge from the defibrillator is transferred to the DA-2003’s load resistance.

3. DA-2003 calculates the energy delivered over the load resistance and displays the result in

joules under RESULT.

If the maximum voltage for a

Note

selected range is exceeded, the LCD display will show ‘WARNING! Overload’

APEX (+) pad → right plate STERNUM pad → left plate

DA-2003 also shows the energy measured, the maximum voltage and the maximum current in

the energy wave. Following the discharge from the defibrillator, DA-2003 shows a playback of the wave from the ECG output. A new pulse can be generated when the LCD display shows 'LOCAL'.

4. Following a discharge from the defibrillator, the instrument shows a playback of the wave from

the ECG output. The display will thus be in playback mode. When this is shown in one line, DA2003 automatically prints out the result.

5. The discharged pulse can be repeated. To do this press more-2 (F5) to advance to page 2 of

the main menu.

Press PLAY PULSE (F2). The display will show 'Oper: Playback,' and displays the result in

joules under RESULT.

Following playback, the apparatus is ready to receive a new discharge from the defibrillator. The

display will show 'LOCAL'.

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6. When testing automatic defibrillators, it is quite common to have to select 'vfib' from the ECG

menu 'ECG WAVE' for the 'ventricular fibrillation' wave. Automatic defibrillators typically do not fire without seeing 'v-fib'.

6.4 Cardioversion Test

1. Select ECG WAVE (F1) from the main menu.

2. The ECG Wave menu opens. DA-2003 includes the following ECG wave selection for cardioversion

tests, or for the testing of electrocardiograph monitors.

Normal Sine Rates: 30, 60, 80, 120, 180, 240 and 300 ECG Arrhythmia types as follows:

vfib Ventricular Fibrillation afib Atrial Fibrillation blk II Second degree A-V block RBBB Right Bundle Branch Block PAC Premature Atrial Contraction PVC_E Early PVC PVC_STD PVC PVCRonT R on T PVC mfPVC Multifocal PVC bigeminy Bigeminy run5PVC Bigeminy Run of 5 PVCs vtach Ventricular Tachycardia

Select a desired wave by pressing UP (F2) or DOWN (F3). Save this under ‘Wave” in the STATUS

field by pressing SELECT (F4). Press CANCEL (F5) to cancel selection.

3. DA-2003 includes the following ECG wave amplitude options:

0.5 mV, 1.0 mV, 1.5 mV and 2.0 mV. To change wave amplitude select more-2 on the main menu to advance to page 2. Select WAVE AMPL. (F1).

BC Biomedical DA-2003 User Manual 11/04

The Wave Amplitude Menu appears:

Select the desired amplitude by pressing UP (F2) or DOWN (F3). Save this under ‘Ampl” in the

STATUS field by pressing SELECT (F4). Press CANCEL (F5) to cancel selection.

4. Set the defibrillator to synchronized cardioversion mode. Discharge the defibrillator over the

instrument's load resistance.

5. DA-2003 measures the time delay in milliseconds (ms) between the top of the 'R' wave and the

discharging of the defibrillator pulse. This delay will be shown in the LCD display as: 'Delay: xxx ms'.

DA-2003 also shows the energy measured, the maximum voltage and the maximum current in the

energy wave. Following the discharge from the defibrillator, DA-2003 shows a playback of the wave from the ECG output. A new pulse can be generated when the LCD display shows 'LOCAL'.

6.5 Maximum Energy Charging Time Test

1. The charge time function is used to test the battery and the charging capacitor in the defibrillator.

2. Set the defibrillator to maximum energy.

3. Securely place the defibrillator paddles on the DA-2003 contact plates, and discharge the

4. Select CHARGE TIME (F3) from the main menu and the charge button on the defibrillator

simultaneously.

APEX (+) pad → right plate STERNUM pad → left plate

When the defibrillator is charged, discharge it through the instrument.

5. Charging time will be shown in the display as ‘Chrg T: xx.x MS’ under RESULT.

BC Biomedical DA-2003 User Manual 11/04

IX. WARRANTY

BC Biomedical warrants that the DA-2003 Defibrillator Analyzer will substantially conform to published specifications and to the documentation, provided that it is used for the purpose for which it was designed. BC Biomedical will, for a period of twelve (12) months from date of purchase, replace or repair any defective analyzer, if the fault is due to a manufacturing defect. In no event will BC Biomedical or its local representatives be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of or inability to use the DA-2003 Defibrillator Analyzer, even if advised of the possibility of such damages. BC Biomedical or its local representatives are not responsible for any costs, loss of profits, loss of data, or claims by third parties due to use of, or inability to use the DA-2003 Defibrillator Analyzer. Neither BC Biomedical nor its local representatives will accept, nor be bound by any other form of guarantee concerning the DA-2003 Defibrillator Analyzer other than this guarantee. Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions; therefore, this statement may not apply to you.

X. TECHNICAL SUPPORT

BC Biomedical’s DA-2003 Defibrillator Analyzer is backed by a superior support staff. If the DA-2003 ever fails to work perfectly, please contact the Technical Support Staff.

Written Communications

You may write a letter with your comments and send it to:

BC Biomedical

BC Group International, Inc.

PO Box 25125

9415 Gentry Ave

St. Louis, MO USA 63125

E-mail: sales@bcgroupintl.com

Phone Support

You can telephone the Technical Assistance Center at 314-638-3800 or 1-800-242-8428 between 8:00 AM and 4:30 PM Central Standard Time (CST) Monday through Friday, except holidays.

Whichever method of contact you choose, please provide the following information:

• Product name and serial number

• Revision level of your software

• The specific steps which reproduce your problem

• Any error codes displayed on screen

• A daytime phone number, fax number, and/or email address (if available)

• Your name / company

BC Biomedical DA-2003 User Manual 11/04

BC Biomedical DA-2003 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual